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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K110280

REVLOK FENESTRATED SCREW SYSTEM · Globus Medical, Inc. · decided 2011-07-06 (SESU)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
REVLOK178.841GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095225426
REVLOK178.827GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095225280
REVLOK178.800GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095225013
REVLOK178.778GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095224795
REVLOK178.712GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095224139
REVLOK178.485SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095222708
REVLOK178.440SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095222494
REVLOK178.347SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095222142
REVLOK178.191SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095221268
REVLOK178.183SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095221183
REVLOK178.098SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095220889
REVLOK178.040SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00849044070163
REVLOK178.020SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00849044070095
REVLOK178.635GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00849044069921
REVLOK178.812GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095225136
REVLOK178.691GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095223927
REVLOK178.561SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095223125
REVLOK178.504SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095222845
REVLOK178.247SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095221541
REVLOK178.167SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095221138
REVLOK178.097SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095220872
REVLOK178.092SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00849044070514
REVLOK178.065SGLOBUS MEDICAL, INC.KWQ MNH MNI NKB00849044070309
REVLOK178.731GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095224320
REVLOK178.698GLOBUS MEDICAL, INC.KWQ MNH MNI NKB00889095223996